Senior Process Equipment Engineer – Biopharma GMP

Catalent Pharma Solutions; Harmans (MD); On-site; USD 94,000 - 128,000; Full time

Benefits offered by this job

Career path

Diverse culture

Career growth

PTO + 8 holidays

Community initiatives

Medical benefits

Tuition reimbursement

Job summary

Catalent Pharma Solutions in Harmans, MD, is seeking a Senior Process Engineer - Equipment to lead the onboarding of new process equipment for gene therapy manufacturing. The role emphasizes commissioning, qualification, and cross‑functional collaboration to ensure validated equipment status in a 100% onsite facility.

The candidate will manage maintenance programs, support GMP quality systems, and drive improvements across upstream, downstream, fill/finish, and packaging operations, with a

Qualifications

• Bachelor’s degree in Engineering (chemical or mechanical preferred).
• At least 4 years of related GMP/biopharma maintenance/engineering experience.
• Strong mechanical, electrical, and automation engineering expertise for bioprocess equipment and control systems.
• Experience with sterile manufacturing operations and aseptic equipment lifecycle.
• Knowledge of cGMP regulations and quality system documentation.

Responsibilities

• Analyze, develop, and implement engineering solutions to improve equipment reliability, quality, safety, and performance.
• Troubleshoot, repair, and optimize bioprocess, fill/finish, packaging, laboratory, and utility equipment and control systems.
• Lead engineering projects from initiation to completion, including planning, scheduling, and contractor oversight.
• Support process scale-up, tech transfer, commissioning, qualification, and validation activities.
• Coordinate with cross-functional teams to maximize equipment uptime and efficiency.

Skills

Mechanical engineering

Electrical engineering

Automation engineering

Troubleshooting

Cross-functional collaboration

Education

Bachelor’s degree in Engineering

Tools

CMMS

Job description

Catalent Pharma Solutions in Harmans, MD, is seeking a Senior Process Engineer - Equipment to lead the onboarding of new process equipment for gene therapy manufacturing. The role emphasizes commissioning, qualification, and cross‑functional collaboration to ensure validated equipment status in a 100% onsite facility.

The candidate will manage maintenance programs, support GMP quality systems, and drive improvements across upstream, downstream, fill/finish, and packaging operations, with a